Chemoradiotherapy
Conditions
Brief summary
To evaluate the efficacy and toxicity of sodium glycididazole combined with concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy.
Detailed description
1. To evaluate the efficacy and toxicity of concurrent chemoradiotherapy combined with sodium glycididazole in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy, and to explore sodium glycididazole as a new way to inhibit the occurrence of radiation esophagitis and reduce the occurrence of radiation pneumonitis and lymphopenia. 2. To evaluate the sensitization effect of sodium glycididazole in the anti-tumor activity during concurrent chemoradiotherapy, as well as the changes in the anti-tumor immune response in peripheral blood, in order to screen out the dominant population and the predictive biomarkers with fewer related toxic and side effects. 3. By exploring the correlation between the expression level of NLRP3 inflammasome activation related molecules and imaging changes in peripheral blood after radiotherapy and the toxicity of radiotherapy and chemotherapy, a risk model for predicting radiation esophagitis after concurrent radiotherapy and chemotherapy for non-small cell lung cancer was further constructed.
Interventions
Sodium glycididazole is intravenously infused at a dose of 800mg at 60 min before radiotherapy and used on Mondays, Wednesdays and Fridays during radiotherapy.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must have histologically or cytologically confirmed non-small cell lung cancer. 2. Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvant therapy. 3. ECOG PS 0-2 4. Adequate organ and bone marrow function.
Exclusion criteria
1. History of previous radiotherapy. 2. The previous immune-related pneumonitis ≥ grade 2. 3. Local lesions require surgery. 4. History of another primary malignancy. 5. History of active primary immunodeficiency. 6. Histological findings showed mixed small cell lung cancer and non-small cell lung cancer. 7. For any unmitigated toxicity during pre-study chemoradiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of grade 3 and above radiation esophagitis | 8 weeks | Radiation esophagitis of grade 3 or higher is graded according to the toxicity criteria of the CTCAE v5.0. |
| Incidence and severity of grade 2 and above radiation pneumonitis | 8 weeks | Radiation pneumonitis of grade 2 or higher is graded according to the toxicity criteria of the CTCAE v5.0. |
Countries
China
Contacts
Primary ContactLei Deng, MD
Outcome results
None listed